NCT00640926已完成2 期
A Phase 2, Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of RX-1741 in the Treatment of Adult Patients With Mild to Moderate Severity of Community-Acquired Pneumonia (CAP)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 158
- 试验地点
- 29
- 主要终点
- Clinical Cure in the Clinically Evaluable (CE) Population at Test of Cure (TOC)
研究概览
简要总结
The purpose of this study is to determine whether RX-1741, an oxazolidinone antibiotic, is safe and effective in the treatment of mild to moderate community acquired pneumonia (CAP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with mild to moderate CAP.
- •Adult men and women ≥18 years.
- •Females must be post-menopausal for at least 1 year or surgically sterile (hysterectomy or tubal ligation).
- •Sexually active males must use a barrier method of birth control during and for 30 days after the study. Their female partner should also use an additional reliable method of contraception during and for 30 days after the study.
- •The patient must present with an acute respiratory illness (≤7 days duration) with which history and physical examination is consistent with a diagnosis of CAP.
- •Patients requiring immediate study drug therapy before serology or culture results are known may be entered with a presumptive diagnosis of CAP based on:
- •A chest radiograph at baseline, which shows a new infiltrate(s) consistent with pneumonia as interpreted by the radiologist or the investigator and subsequently confirmed by the radiologist.
- •AND at least 2 of the following signs and symptoms:
- •New or increased cough. Purulent sputum or change in sputum character. Auscultatory findings consistent with pneumonia. New onset or progressive dyspnea or tachypnea. Fever >38ºC oral or >38.5ºC tympanic. White blood cell (WBC) count greater than 10,000 cells/mm3 or >15% immature neutrophils (bands), regardless of total peripheral WBC count, or less than 4,500 cells/mm
- •Patient must be able to swallow large capsules intact.
- •A written, voluntarily signed informed consent must be obtained from the patient prior to the initiation of any study-related procedures.
排除标准
- •Hypersensitivity to linezolid.
- •Patients are excluded if they have taken oral or parenteral antibiotics as follows:
- •long-acting penicillin within 28 days of enrollment azithromycin, ceftriaxone, or telithromycin within 14 days prior to enrollment any other antibiotics for >24 hours within 3 days of enrollment
- •Require parenteral antibiotics for the treatment for CAP.
- •Patient should not have been hospitalized or resided in a long-term facility for at least 14 days before the onset of symptoms.
- •Evidence of other pulmonary disease that precluded evaluation of therapeutic response. Patients with known bronchial obstruction or a history of postobstructive pneumonia. (This does not exclude patients who have chronic obstructive pulmonary disease).
- •Experienced a recent clinically significant coagulopathy.
- •History of cystic fibrosis, active tuberculosis, meningitis, endocarditis, or osteomyelitis.
- •Immunocompromised patients including, but not limited to patients with a CD4+ cell count of <350 cells/mm3 secondary to human immunodeficiency virus (HIV) infection, neutropenic patients with granulocytes <1000/mm3 or immunosuppression secondary to drugs such as corticosteroid therapy (>10 mg/day of prednisone or equivalent for at least the past 3 months), splenectomized patients or patients with known hyposplenia or asplenia.
- •Patients who have severe liver disease.
- •Treatment with an investigational drug within 4 weeks prior to study drug administration.
- •Any underlying condition or disease state that would interfere with the completion of the study procedures and evaluation of the absorption of study drug.
- •Patients with bronchiectasis and a history of recent respiratory infection caused by Pseudomonas aeruginosa.
- •Any infection which requires the use of a concomitant antimicrobial agent, in addition to study drug.
- •Patients taking serotonergic agents, selective serotonin reuptake inhibitors (SSRIs) or monoamine oxidase inhibitors (MAOIs).
研究组 & 干预措施
1
Experimental
Radezolid 300 mg
干预措施: Radezolid (Drug)
2
Experimental
Radezolid 450 mg
干预措施: Radezolid (Drug)
3
Experimental
Radezolid 450 mg BID
干预措施: Radezolid (Drug)
结局指标
主要结局
Clinical Cure in the Clinically Evaluable (CE) Population at Test of Cure (TOC)
时间窗: Study days 14-38
Patients were considered cured if all systemic signs and symptoms of CAP present at screening were improved or resolved and no further antibiotic therapy was necessary. In addition, the follow-up chest X-ray was to be either stable or improved.
次要结局
未报告次要终点
研究者
研究点 (29)
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